Systems and methods for fluid sample collection and testing

ABSTRACT

A fluid sample testing apparatus has a housing with a test chamber and first and second fluid collector tubes and first and second fluid collectors in fluid communication with the test chamber. A sample holding container is in fluid communication with the second fluid collector tube. The first fluid collector is inserted into the first fluid collector tube and pressure is generated to release fluid from the first fluid collector into the test chamber, and air passes outside of the apparatus from the test chamber via an opening from the test chamber into the first fluid collector tube. The second fluid collector is inserted into the second fluid collector tube concurrently and pressure is generated to release fluid from the second fluid collector into the sample holding container, and air passes outside of the apparatus from the second fluid collector tube.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to Provisional App. No. 62/805,879filed Feb. 14, 2019 and Provisional App. No. 62/970,663 filed Feb. 5,2020 (both of which include common Applicants hereof), which are herebyincorporated by reference.

FIELD OF THE INVENTION

The present invention relates to substance collection and testingparticularly fluid samples, and more particularly the present inventionrelates to a device that tests a fluid sample for the presence orabsence of at least one analyte with improved fluid and air flowcharacteristics, preferably (but optionally) securing a separate fluidsample for later confirmation, and preferably (but optionally) providingpositive identification of an individual associated with the sample. The“dual swab” embodiments referenced therein and herein are sometimesreferred to herein as a “Dual Swab Device.” Embodiments thereof havingonly a “single swab” are referred to herein as a “Single Swab Device.”Both Dual Swab Devices and Single Swab Devices are within the scope ofthe present invention and preferably include lateral flow assay stripsin a test strip chamber, and preferably may have dual or single teststrip cassettes in the test strip chamber as herein after described.

BACKGROUND OF THE INVENTION

Reference is made to co-pending U.S. application Ser. Nos. 15/417,905and 15/418,044, which are hereby incorporated by reference (“ReferencedPatent Documents”) (but see in particular FIGS. 19-25 of the '044application and related description, and the '905 application in itsentirety).

Drug and other analyte testing has become ubiquitous in modem society.In homes, doctors' offices, law enforcement vehicles and offices,athletic facilities, and the workplace, effective, inexpensive andreliable testing devices have been sought. There is also a growing needfor devices to test bodily fluids for substances that may assist in thediagnosis or management of diseases and other medical conditions.

The marketplace responded and is now replete with many devices directedto the testing of blood, urine or saliva. However, these devices mayrequire a series of tests involving the shifting of the fluid samplebeing tested to different containers and/or the removal of the fluidsample to distant locations. These devices may also require the testadministrator to handle the test subject's bodily fluids, incurring adanger of disease exposure.

Once an initial test result has been obtained, further testing of thesame fluid sample to confirm or refine the initial test result is oftenrequired. For a membrane test strip device, the fluid sample may noteven be retained once the initial result is obtained, necessitatingretention of a split sample. The need to retain a split sample incursthe risk that a sample could be lost, mislabeled, or contaminated.

Oftentimes, the chain of custody associated with a test sample imbuesthe results with doubt, as the fluid sample may become contaminated,misplaced or a different fluid sample may be substituted entirety. Inmany instances, identification of the test subject associated with thefluid sample is critically dispositive.

Prior art testing devices include those disclosed in U.S. Pat. Nos.7,879,623 and 8,940,527, both entitled “Integrated Device for Analyte,Testing, Confirmation, and Donor Identity Verification” and bothidentifying Raouf A. Guirguis as the sole inventor. U.S. Pat. Nos.7,879,623 and 8,940,527 are both hereby incorporated by reference. Thepatents disclose an apparatus for fluid sample collection and analytetesting, including a single sample receiving member and at least onemembrane test strip, and optionally a sample retention member,fingerprint acquisition pad, and/or fluid collector. It also provides afluid collection apparatus having an absorbent material, compressionelement, and closure element, and optionally a lid that allows theapparatus to be used in conjunction with a fluid container. Alsoprovided are methods of collecting, testing, and retaining a fluidsample and verifying the identity of one or more individuals associatedwith the sample, such as the test subject, test administrator, and/orwitnesses. The components for collecting, testing, and retaining a fluidsample are in fluid communication with the other components of thetesting device.

There is also a growing need for devices directed to testing forcontaminants that may be found in food or water, such as pollutants,allergens, and harmful microbes. In some instances, it may be desirableto retain a fluid sample for confirmation testing or further analysis,retain a split fluid sample of the original sample for confirmationtesting or further analysis, or to provide positive identification ofthe test administrator.

The Department of Transportation's (DOT) rule, 49 C.F.R. Part 40,describes required procedures for conducting workplace drug and alcoholtesting for the Federally regulated transportation industry. Within thisrule, definitions for split sample and split sample collection areprovided. Split specimen is defined as, in drug testing, a part of theurine specimen that is sent to a first laboratory and retained unopened,and which is transported to a second laboratory in the event that theemployee requests that it be tested following a verified positive testof the primary specimen or a verified adulterated or substituted testresult. Split specimen collection is defined as a collection in whichthe urine collected is divided into two separate specimen bottles, theprimary specimen (Bottle A) and the split specimen (Bottle B).

Thus, a need exists in the industry to combine the simplicity of currentmembrane test strip technology with the ability to positively identifythe test subject and/or the test administrator, as well as thecapability to secure a split portion of the fluid sample with a singledevice for later confirmation, within a single device.

Also, a need exists in the industry for such devices to have reduced“push pressure” for locking the swab or swabs in the device, whichfacilitates operation by users of varying physical strength. And a needalso exists for improved test strip carriers for strip testingsubstances with a propensity to bind or stick to various surfaces, sucha substance being THC.

Also incorporated by reference herein are the disclosures of U.S. Pat.Nos. 9,414,813 and 10,035,146.

SUMMARY OF THE INVENTION

In accordance with certain preferred embodiments of the presentinvention, a fluid sample testing apparatus has: a housing with a testchamber and a first fluid collector tube of a first diameter and asecond fluid collector tube of a second diameter, wherein the testchamber is in fluid communication with the first fluid collector tube; asample holding container in fluid communication with the second fluidcollector tube; and first and second fluid collectors, wherein the firstfluid collector is adapted for insertion into the first fluid collectortube and upon insertion into the first fluid collector tube pressure isgenerated to release fluid from the first fluid collector into the testchamber via an opening between the test chamber and the first fluidcollector tube, wherein air passes outside of the apparatus from thetest chamber via an opening from the test chamber into the first fluidcollector tube, and wherein the second fluid collector is adapted forinsertion into the second fluid collector tube concurrently withinsertion of the first fluid collector into the first fluid collectortube and upon insertion into the second fluid collector tube pressure isgenerated to release fluid from the second fluid collector into thesample holding container, wherein air passes outside of the apparatusfrom the second fluid collector tube. The apparatus may have the firstfluid collector having an upper sealing portion such that uponsubstantially complete insertion into the first fluid collector tube theupper sealing portion seals the opening between the test chamber and thefirst fluid collector swab tube. The apparatus may have the second fluidcollector tube having a shoulder portion in proximity to the sampleholding container of a diameter smaller than the second diameter,wherein the second fluid collector has a lower sealing portion such thatupon substantially complete insertion into the second fluid collectortube the lower sealing portion seals the sample holding container froman upper portion of the second fluid collector tube. The first andsecond fluid collectors may comprise individual single swabs coupledtogether with a locked cap. The second diameter preferably is greaterthan the first diameter. The test chamber preferably has a top capconnected to the housing that is sealed from outside of the apparatus,preferably in an air and water tight manner such as by sonic welding.

Embodiments of the invention further include a cassette for holding oneor a plurality of test strips, wherein the cassette includes one or morechannels for holding the one or more test strips and includes at least afirst channel for holding a first strip, the first channel having aplurality of projections from each of two opposite side walls of thefirst channel, wherein the plurality of projections define a centerportion in which the first strip is positioned, wherein the plurality ofprojections position the first strip to reduce or prevent contactbetween the first strip and the side walls of the first channel, whereinthe first channel also has a floor having a plurality of raisedportions, wherein the plurality of raised portions position the firststrip to reduce or prevent contact between the first strip and the floorof the first channel. Bumps on the front face of the cassette also areprovided in certain embodiments, as are side legs that are tapered orhave a smaller dimension at a bottom portion compared to a largerdimension at an upper portion.

Embodiments of the present invention also include a fluid sample testingapparatus having a housing with a test chamber and a first fluidcollector tube of a first diameter and a second fluid collector tube ofa second diameter, wherein the test chamber is in fluid communicationwith the first fluid collector tube; a sample holding container in fluidcommunication with the second fluid collector tube; first and secondfluid collectors, wherein the first fluid collector is adapted forinsertion into the first fluid collector tube and upon insertion intothe first fluid collector tube pressure is generated to release fluidfrom the first fluid collector into the test chamber via an openingbetween the test chamber and the first fluid collector tube, wherein airpasses outside of the apparatus from the test chamber via an openingfrom the test chamber into the first fluid collector tube, and whereinthe second fluid collector is adapted for insertion into the secondfluid collector tube concurrently with insertion of the first fluidcollector into the first fluid collector tube and upon insertion intothe second fluid collector tube pressure is generated to release fluidfrom the second fluid collector into the sample holding container; and agasket positioned in the second fluid collector tube having an upperportion for engaging a wall of the second fluid collector tube and alower portion of smaller diameter than the upper portion for insertioninto an opening of the sample holding container, wherein the gasket ispositioned at an upper location in the second fluid collector tube uponinsertion of the second fluid collector into the second fluid collectortube, wherein the gasket is positioned at a lower location in the secondfluid collector tube after insertion of the second fluid collector intothe second fluid collector tube and at the lower location the gasketforms a seal with the sample holding container, wherein air passesoutside of the apparatus from the second fluid collector tube before thegasket is positioned at the lower location.

The first fluid collector may have an upper sealing portion such thatupon substantially complete insertion into the first fluid collectortube the upper sealing portion seals an opening between the test chamberand the first fluid collector swab tube. The apparatus may have thefirst fluid collector having a lower sealing portion adapted to form asliding seal between the lower sealing portion and a surface wall of thefirst fluid collector tube as the first fluid collector is inserted intothe first fluid collector tube. The upper sealing portion may be adaptedto form a fixed seal for the opening between the test chamber and thefirst fluid collector tube and have a shape different from the lowersealing portion. The upper sealing portion may form a stopper seal forthe opening between the test chamber and the first fluid collector tube,and the lower sealing portion may form a syringe plunger seal betweenthe lower sealing portion and a surface wall of the first fluidcollector tube. The lower sealing portion may be formed to have aplurality of spaced apart o-ring portions to form the syringe plungerseal. The lower sealing portion may be formed to have a textured surfaceto form the syringe plunger seal.

Accordingly, it is an object of the present invention to provide singleand dual swab fluid collection and testing devices having improved airventing/air flow characteristics to improve fluid transfer into a testchamber via a channel and optionally into a confirmation vial.

It is another object of the present invention to provide single and dualswab fluid collection and testing devices having improved userexperience by having reduced back pressure when swab assemblies areinserted into and pressured downward in a preferably locked position.

It is yet another object of the present invention to provide swabassemblies having a stopper type upper seal and a syringe type lowerseal.

It further is an object of the present invention to provide a fluidcollection apparatus having a funnel shaped gasket in a first positionwhereby a swab may be initially compressed, and upon pressure build-upmove to a second position whereby the gasket seals to the housing andvial, wherein prior to being in the second position air may vent out ofthe apparatus.

Finally, it is an object of the present invention to provide a stripholding cassette for use in testing fluid samples having one or morechannels with side projections and floor bumps that position a strip soas to reduce or prevent contact of the strip with side walls of thechannel or a floor of the channel.

BRIEF DESCRIPTION OF THE DRAWINGS

The above objects and other advantages of the present invention willbecome more apparent by describing in detail the preferred embodimentsof the present invention with reference to the attached drawings inwhich:

FIGS. 1-3 illustrate overall device views of a fluid sample collectionand testing device in accordance with certain preferred embodiments ofthe present invention;

FIG. 4 illustrates fluid communication between a swab tube and a testchamber and between a swab tube and a confirmation vial in accordancewith certain preferred embodiments of the present invention;

FIGS. 5A and 5B illustrate a top cap preferably sonic weldable inaccordance with certain preferred embodiments of the present invention;

FIGS. 6A-6C illustrate a swab stem and a swab assembly in accordancewith certain preferred embodiments of the present invention;

FIG. 7 illustrates a dual swab stem handle for connecting two swabassemblies to make a dual swab assembly in accordance with certainpreferred embodiments of the present invention;

FIG. 8 illustrates a dual swab assembly in accordance with certainpreferred embodiments of the present invention;

FIGS. 9-10 illustrate overall device views of a fluid sample collectionand testing device in accordance with additional certain preferredembodiments of the present invention;

FIGS. 11A and 11B illustrate a top cap preferably sonic weldable inaccordance with additional certain preferred embodiments of the presentinvention;

FIG. 12 illustrates a dual swab stem handle for connecting two swabassemblies to make a dual swab assembly and a top cap therefor inaccordance with additional certain preferred embodiments of the presentinvention;

FIG. 13 illustrates a lockable bottom cap for a fluid sample collectionand testing device in accordance with additional certain preferredembodiments of the present invention;

FIGS. 14 and 15 illustrate a vial confirmation stem tube ventingimplement for a fluid sample collection and testing device in accordancewith certain preferred embodiments of the present invention;

FIGS. 16A-16D illustrate certain floor properties and other attributesof a test chamber and a ventable/sealable gasket for a fluid samplecollection and testing device in accordance with certain preferredembodiments of the present invention;

FIG. 17 illustrates an improved cassette for holding test strips for afluid sample collection and testing device in accordance with certainpreferred embodiments of the present invention;

FIGS. 18A-18B illustrate a ventable/sealable gasket for a fluid samplecollection and testing device in accordance with certain preferredembodiments of the present invention; and

FIG. 19 illustrate a swab assembly-housing holding clip for a fluidsample collection and testing device in accordance with certainpreferred embodiments of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention will be described in greater detail with referenceto certain preferred and alternative embodiments. As described below,refinements and substitutions of the various embodiments are possiblebased on the principles and teachings herein.

As will be understood from the Referenced Patent Documents, particularlyin view of this disclosure, the present invention utilizes a fluid(e.g., saliva) absorption or capture device (herein a “swab” orsponge/sponge-like material that may absorb/contain and release thefluid of interest) that preferably captures oral fluids such as byinsertion of the swab into a subject's mouth, whereby oral fluids arecaptured/absorbed into the swab (where the term “saliva” is used, it isto be understood that other than oral fluids also may be used inaccordance with embodiments of the present invention). As anillustrative example, in accordance with alternative embodiments of thepresent invention, a swab may be wetted with water or other fluid suchas alcohol, then brought into contact with a dry, powder or othersubstance (which may be suspected to be a drug, contaminant or othermaterial of interest or concern), and then swabs inserted into thedevice for testing. Each swab preferably is mounted on a stem typedevice so that the absorbent material of the swab/sponge may be readilypositioned in the subject's mouth, with the stem holdable much like alollipop. After a sufficient amount of time, e.g., 2-5 minutes, andpreferably as indicated by an indicator implement (hereinafterdescribed), saliva typically is captured in sufficient volume so as tobe introduced via a dual swab into the housing of a Dual Swab Device fortesting and preferably confirmation (as will be described in more detailhereinafter). In alternative Single Swab Devices, saliva typically iscaptured in sufficient volume so as to be introduced via a single swabinto the housing of a Single Swab Device for testing (as will bedescribed in more detail hereinafter). In both Single and Dual SwabDevices, insertion of the swab via the stem into the housing preferablycauses compression of the swab into a bottom portion of a swab tube inthe housing, forcing saliva to be released from the swab whereinpressure is generated such that saliva is forced or pushed from the swabtube into a lateral flow assay strip chamber through an opening sizedfor the particular fluid under examination (there is flow communicationvia a channel from the swab tube in the housing into strip chamber). Thesaliva contacts the strips whereby the previous of drugs, diseases orother substances may be detected in desirable levels (see the ReferencedPatent Document). In Dual Swab Devices, a second swab tube is providedso that a second swab may be compressed such that saliva is released andcaptured into a vial, separate from the chamber described above housingthe assay strips. Upon full insertion of the dual swabs, the unit issealed so as to minimize fluid escape from the device. In Dual SwabDevices, a relatively prompt initial screening may be made via the assaystrips, and a second sample is captured in the vial, which is separatefrom, and not in flow communication with, the chamber housing thestrips, which may be made available for confirmation testing in alaboratory, such as in a high complexity via for example massspectroscopy, such as Liquid Chromatography Mass Spectroscopy (LC-MS).In Single Swab Devices, the confirmation vial is not provided, and onlythe screening via the assay strips preferably is provided.

Referring now to FIGS. 1 and 2, an assembled Dual Swab Device 1 isillustrated. Housing 2 (preferably plastic such poly carbonate PC orgeneral purpose polystyrene GPPS or similar materials) provide the mainbody of the unit. In a test chamber as illustrated, strip card/carrieror cassette 3 is provided, which includes one or a plurality of assaystrips generally illustrated as 7. In operation, fluids are introducedinto test chamber 2C of housing 2 so that the presence or absence of oneor more target analytes (e.g., drugs, disease markers, etc.) may bedetected based on the particular characteristics of the one or morestrips 7. Test chamber 2C of housing 2 has an upper body plug or top cap4, which preferably is sonic welding to housing 2 to provide an air andwater tight seal, with the sonic welding carried out after cassette 3has been inserted into test chamber 2C. As illustrated, a Dual SwabDevice preferably includes two swab assemblies, connected via apreferably snap together, locking cap or dual stem handle 8 (each swabassembly is inserted into stem handle 8 and each has a locking featurefor engaging a corresponding feature in stem handle 8 to lock themtogether to create a dual swab assembly). Each of swab assemblies 5A and5B consist generally of the following: stems 6A and 6B (preferablyplastics such as described for housing 2) having at least a visualwindow (indicated by ovals in FIG. 1) such that color changes of anindicator strip inside of stems 6A and 6B may be visible to an observer(and possibly the subject) (indicator strips are described in greaterdetail hereinafter, and such description is applicable here); preferablysoft or elastomeric type material (such as by “second shotting” or “overmolding” provide seals 9A and 9B at an upper portion of the swabassemblies, and seals 11A and 11B at a lower portion of the swabassemblies; swabs 12A and 12B (absorbent or sponge like material, suchas described elsewhere herein), preferably secured by adhesive or otherattachment, are secured to the bottom of stems 6A and 6B and provide thesaliva capture for the devices (shown in compressed form in FIG. 1);tooth rests 10A and 10B, preferably of a similar material as seals 9A,9B, 11A and 11B, are preferably provided so that a comfortable anddesired resting place for front teeth of the subject (this enables theswab stem to be more comfortably held in a manner so that swabs 12A and12B may more optimally capture oral fluids, etc.). Vial 15 is providedin Dual Swab Devices so that a confirmation sample may be obtained. Vial15 preferably is secured to housing 2 via threads 14 of housing 2 orsimilar securing mechanism , and preferably sealed with 0 ring 16. Asshould be understood based on the description herein, swab assembly 5Amay be compressed in tube 2A of housing 2 (see FIG. 3) and release oralfluid into vial 15 via fluid channel 2D (vial 15 is in fluidcommunication with tube 2A as illustrated), and swab assembly 5B may becompressed in tube 2B of housing 2 and release oral fluid into testchamber 2C via channel 23 (see FIG. 4) (test chamber 2C is in fluidcommunication with tube 2B via channel 23 as illustrated).

FIG. 3 illustrates additional attributes of preferred embodiments of thepresent invention, in cross section. Focusing now on the left most swabassembly 5B and swab tube 2B of housing 2 (herein sometimes called the“strip swab tube”), strip swab assembly 5B is shown in cross sectionfully inserted into the strip swab tube (swab 12B is compressed). Swabtube 2B preferably has a diameter of a first dimension, and seal 11B hasa dimension such as to form a relatively tight fit/seal with swab tube2B. As strip swab assembly 5B is inserted into swab tube 2B, therelatively tight fit/seal causes compression of swab 12B (and salivarelease from the swab) and results in interior pressure in the lowerportion of the swab tube 2B, with the result that saliva is releasedfrom swab 12B and forced or pressured moved into test chamber 2C ofhousing 2 via an opening (see opening or saliva passage 23 of FIG. 4).The size of this opening preferably is determined based on, for example,the particular fluid being tested and its characteristics, such asviscosity. What is important is that the relatively tight fit/seal ofswab assembly 5B and the diameters of swab tube 2B and seal 11B are suchthat a plunger/compressive effect is achieved, and saliva is releasedand forced via opening/passage 23 into test chamber 2C. As interiorpressure in test chamber 2C of housing 2 can increase, in preferredembodiment air is vented from test chamber 2C into test swab tube 2B viaa vent opening (see opening/vent 20 of FIG. 3, which provides flowcommunication for air venting between test chamber 2C and swab tube 2B).Note that there is not a seal present at the top of swab tube 2B whileswab assembly 5B is being inserted (stem 6B of swab assembly 5B beingless in cross section than the interior dimension of swab tube 2B).Thus, while being inserted, pressure from the compressed swab forcessaliva into test chamber2C, air is vented from test chamber 2C viaopening/vent 20 into swab tube 2B where it may escape out the top,thereby reducing “back pressure” experienced by the user pushing swabassemblies 5A and 5B into housing 2. Once swab assembly 5B, however, isfully inserted into swab tube 2B (and preferably locked such as with alocking tab—see FIG. 7 and dual stem handle 8 and locking tab 8A, whichwill be understood to engage with an indentation or hole of an upperportion of the tube section of housing 2 to provide a lockingmechanism), seal 9B seals swab assembly 5B against swab tube 2B ANDseals off opening/vent 20. Thus, operationally, opening/vent 20 allowsair release during the insertion process (to prevent pressure build-upin the test chamber as saliva is forced in), and then is closed by apreferably overmold seal upon full insertion of the swab tube assembly.

The right most swab tube 2A of housing 2 (herein sometimes referred toas “confirmation swab tube”) operationally receives swab assembly 5A.Swab tube 5A has a second dimension (illustrated as 2E preferably downto a lower extremity as illustrated), and seal 11A has a diameter suchas to form a relatively loose fit/seal with swab tube 5A (and is not airtight but substantially water tight). Thus, upon insertion of swabassembly 5A into swab tube 2A, swab 12A is compressed and saliva isreleased into vial 15 via fluid channel 2D, while air may be vented outvia the top of swab tube 2A around lower seal 11A. Swab tube 2Apreferably has a shoulder (narrower diameter of a third dimension, lessthan the second dimension, generally illustrated as 2F) at a lowerportion such that seal 11A may tightly engage the shoulder (2F) and sealvial 15 from other portions of the unit upon swab assembly 5A beingfully inserted into swab tube 2A (see seal 11A in FIG. 4, showing theengagement of seal 11A with the shoulder (2F) of swab tube 2A). FIG. 4also illustrates a seal between vial 15 and housing 2 (see o-ring seal16 of FIG. 4), and securing of vial 15 to housing 2 such as by a threadmechanism (see vial threads 26 of FIG. 4, which engage correspondingthreads 14 of housing 2). What is important is that, while swabassemblies 5A and 5B preferably are of the same size, the diameters ofswab tube 2B and swab tube 2A are of different dimensions, such thatpressure is generated to force saliva into test chamber 2D (with airvented from test chamber 2D via opening/vent 20 to swab tube 2B), andair from confirmation swab tube 2A is vented from the top ofconfirmation swab tube 2A. In exemplary preferred embodiments, the thirddimension is less than the first and second dimensions.

FIGS. 5A and 5B illustrate body top cap 4, which is sealed to the top ofthe test chamber of housing 2 preferably via sonic weld to create a airand water tight seal. Body top cap 4 preferably has energy director 4Asuch as to facilitate the sonic weld process.

FIGS. 6A-6C illustrate swab assembly 5A is various stages ofmanufacture. FIG. 6A will be understood to be after the first shot, orfirst injection molding, of the plastic of swab assembly 5A (stem 6A isillustrated). FIG. 6B will be understood to be after the second shot, orsecond injection molding of the softer, more compliant material that isused, preferably, for seals 11A and 11B and teeth rests 10A and 10B asdescribed elsewhere herein. FIG. 6C illustrates swab assembly 5A incross section such that indicator strip 27 is visible. In preferredembodiments, swab assembly 5A (and preferably 5B) has interior portionwith an opening (preferably a slit) such that an indicator strip 27 maybe positioned to engage with swab 12A at one end (illustrated as contactpoint 27A), and then extend up stem 6A so as to be visible through theoval window of stem 6A. As will be understood, indicator strip 27changes color when wet or saturated, and is calibrated/configures toserve as an indicator that a substantial and preferably sufficientamount of saliva has been captured by swabs 12A and 12B so that uponinsertion of the swab assemblies (1) strips 7 are activated to provide aquick screening for target substances/analytes, etc., and saliva iscaptured in vial 15 for subsequent laboratory/confirmation testing ifneeded or desired. Preferably, indicator strip 27 is visible to anobserver and/or subject and provides a confidence indicator thatsufficient saliva has been captured prior to insertion of swabassemblies 5A and 5B into housing 2.

As will be understood, the present invention encompasses both Single andDual Swab Devices. In a Single Swab Device, swab tube 2A, swab assembly5A, vial 15, etc. are not included, and thus housing 2 may be smaller(and not, for example, include the lower skirt portion that surround andprotects vial 15. In preferred embodiments, however, both Single andDual Swab Devices are provided with a common swab assembly (such thatrobotic equipment may be commonly used for production of both Single andDual Swab Devices), and a dual swab assembly is produced by securing twosingle swab assemblies 5A and 5 with dual stem handle 8 (see, e.g., FIG.7). Having a single swab assembly commonly used for Single and Dual SwabDevices with a locking swab step handle (such as with locking tab 8B,which locks into a corresponding feature of swab stems 6A and 6B, suchas illustrated and/or described elsewhere herein) provides significantadvantages in assembly cost and time. FIG. 8 is a view of a dual swabassembly using dual stem handle, shown an exemplary locking tab forsecuring permanently (absent breakage) two single swab assemblies into adual swab assembly. As will be understood, stem handle 8 is adapted tohaving an opening and locking mechanism to secure only one swab assemblyin Single Swab Device embodiments, as will be understood by one of skillin the art.

The present invention may utilize a wide variety of strips as desiredfor the particular application. In one additional attribute, a striptesting for THC (parent or metabolite) is positioned in proximity to theopening to swab tube 2B so that saliva may be initially forced onto theTHC sensing strip. Increased efficiency of THC testing is an importantattribute of the present invention. See other description elsewhere foradditional exemplary strips and analytes, etc.

Referring now to FIGS. 9-19, additional exemplary preferred embodimentswill be described. As illustrated in FIG. 9, housing 2 in alternativepreferred embodiments include interior tabs 2AA near the bottom ofhousing 2. Tabs 2AA extends downward in a bottom cavity portion ofhousing 2 as also illustrated in FIG. 10, and includes openings 2BB.Such preferred embodiments preferably include bottom cap 34, whichincludes tabs 35 with projections 36 (in certain preferred embodimentstwo of such projections 36 are provided), and projections 36 engage withopenings 2BB such that bottom cap 34 preferably is locked onto housing2. In such preferred embodiments, bottom cap 34 includes key opening36A, into which a key or tool (illustrated by dotted lines 36B in FIG.13) may be inserted to cause projections 36 to disengage from openings2BB such that bottom cap 34 may be removed from housing 2. In certainpreferred embodiments, tape 36C (which may be an adhesive or otherblocking material that is puncturable) covers opening 36A, therebyproviding evidence of tampering or lack thereof. In operation, tool 36B(or other protrusion) punctures tape 36C in order to engage projections36 (in order to remove bottom cap 34). In this manner, vial 32 (similarto vial 15, described elsewhere herein) may be accessed for removal,such as for having a laboratory confirmation of the preferably oralfluid sample there preferably using an LC MS machine, by puncture oftape 36C and removal of bottom cap 34. Intact tape 36C is evidence thatthe unit has not been opened or tampered with.

Additional details of bottom cap 34 are shown for illustrative purposesin FIG. 13, which illustrates tool 36B (shown as dotted lines in FIG. 13to illustrate a member that is inserted into opening 36A to spreadprojections 36 to facilitate removal of bottom cap 34) engaging tabs 35to cause movement of projections 36 (so as to disengage from openings2BB). Tool 36B is illustrated to have two parallel or substantiallyparallel projecting members (shaped much like a flat head screwdrivertip) that engage with tabs 35. The precise shape may vary; what isimportant is that tool 36B be projectable through hole 36A and causemovement of projections 36 to enough bottom cap 34 to be removed via thetool. Bottom cap 34 preferably (but optionally) includes opening 32Ainto which the bottom end of vial 32 extends, facilitating viewing ofvial 32 from the bottom, etc. Ribs or members 32B are provided to engagevial 32 and help ensure that vial stays securely in housing 2 (and isnot, for example, loosened such as by vibration during transport of thedevice). Contact between ribs/members 32B put pressure on vial 32,causing vial 32 to resist rotational unthreading from housing 2. Vial 32is secured to housing 2 via threads 37 (similar to threads describedelsewhere herein).

Referring again to FIG. 9 and also FIGS. 11A and 11B, alternative upperbody top cap 4′ is illustrated. Top cap 4′ preferably has a flat top 4Cas illustrated and preferably includes tabs 4B extends downward toengage strip card/carrier (or cassette) 3, helping to hold cassette 3 inplace so that the bottom tips of the strips carried by cassette 3 arepositioned in proximity to the bottom of test chamber 2C of housing 2 soas to contact oral fluid when the device is in operation. Top cap 4′preferably includes sonic welding energy director surface 4A, whichengages housing 2 so that it may be adhered to housing 2 preferably bysonic welding. While adhesives or other securing elements may be used tosecure top cap 4′ to housing 2, it has been determined that sonicwelding preferably provides a low cost and air and water tight securesecuring mechanism, also providing tamper resistance to the stripswithin test chamber 2C (venting is provided by opening 20, sealed byseal 11B, such as described elsewhere herein).

Referring again to FIG. 9, swab assemblies 5A and 5B are illustrated ina downward and locked position. Also as illustrated, each of swab stems6A and 6B include saliva indicator strips 6D (similar to indicator strip27 described elsewhere herein), each of which includes a color changingregion 6C, which preferably changes (for example) from a first color(e.g., white) to a second color (e.g., red) when oral fluid wicks upfrom the swab absorbent tip (swabs 12A and 12B) onto strips 6D in swabstems 6A and 6B. In preferred embodiments, indicator strips 6D enable anindication of adequate oral fluid being absorbed in swabs or sponges 12Aand 12B (see also FIGS. 1-6C) such that oral fluid will contact teststrips in cassette 3 and occupy a substantial volume of vial 32 whenswab assemblies 5A and 5B are inserted and locked into housing 2. Asillustrated, indicator strips 6D (or 27) may have color changing region6C on one of the indicator strip, and in preferred embodiments colorchanging regions 6C on both swabs of a Dual Swab Device face commonly inan up or down direction as illustrated.

Referring again to FIGS. 9 and 10, further sealing attributes of theadditional exemplary preferred embodiments will be described. Asdescribed previously, seals 9A, 9B, were provided at the upper portionof swab stems 6A and 6B, which will be understood to provide a seal tothe outside from the interior of both swab tubes 2A and 2B by pressurecontact with the walls of swab tubes 2A and 2B by seals 9A and 9B. Seal9B serves the additional purpose of sealing opening/vent 20 when swabassemblies 5A and 5B are in a fully inserted and preferably lockedposition in housing 2. As will be appreciated from the drawings and thedescription herein, Seals 9A and 9B are adapted to form a type ofstopper seal, or a rounded contour seal, for opening/vent 20 and thetops of swab tubes 2A and 2B. In the previously described exemplarypreferred embodiments, lower seals 11A and 11B are formed similarly toseals 9A and 9B. In alternate exemplary preferred embodiments, sealed11A and 11B are formed in a different manner.

FIGS. 9 and 10 illustrate lower seals 11A′ and 11B′ (shown in crosssection) having a shape adapted to form a sliding seal (rather than astopper seal). Applicants have determined that in certain embodimentshaving a sliding type or syringe type lower seal enables swab assemblyinsertion into the swab tubes with reduced friction or resistance. Asillustrated in such embodiments, seals 11A′ and 11B′ preferably areformed to have a contoured or textured profile, as compared to therounded contour of seals 9A and 9B. In one illustrative example, seals11A′ and 11B′ have one or more preferably a plurality (two being shownas an example) fins or o-rings (projecting sealing members, etc.),preferably spaced apart as illustrated but formed in a unitary manner,such as by a second shot or overmold injection molding process. Suchfins or o-rings provided a sliding seal or a syringe seal to prevent orinhibit fluid travel up as the swab assemblies 5A and 5B are insertedand moved downwardly in swab tubes 2A and 2B. As swabs 12A and 12B arecompressed by downward movement of swab assemblies 5A and 5B into swabtubes 2A and 2B and fluid is released from swabs 12A and 12B, pressurebuilds, and sealing is provided by seals 11A′ and 11B′ to inhibit upwardflow of the fluid towards the top of the housing, thereby facilitatingfluid flow into vial 32 and test chamber 2C. At the same time, userexperience degrades if the force required to fully insert swabassemblies 5A and 5B is too great, and thus, swab seals 11A′ and 11B′are provided in a form that provides an adequate seal with improvedslide resistance by having a contoured or finned structure or texturedshape. In yet further alternative embodiments, seals 11A′ and 11B′ aretextured in a manner to reduce sliding resistance rather than withprojection-style fins or o-rings in a manner to provide asliding/syringe type seal, again as compared to the stopper type seal ofseals 9A and 9B. What is important is that each of seals 9A/9B and11A′/11B′ are adapted and formed optimally for their particularfunctions, which is understood from the description and drawingsprovided herein, and preferably formed from the same manufacturingsteps, such as a second shot or overmold injection molding process thatform both types of seals on swab stems 6A and 6B.

The additional exemplary preferred embodiments illustrated in FIGS. 9-19also include a vented thread/gasket sealing mechanism, which is furtherillustrated and described herein. FIGS. 9, 10, 16A-16D, 18A and 18Billustrate gasket 30, preferably shaped much like a funnel, andpreferably having extending portion 30D that extends into vial 32 andchannels a flow of fluid (which may be oral fluid) into vial 32 as swab12A is compressed upon insertion into housing 2. Gasket 30 has opening30F through which fluid passes into vial 32. In a first positionillustrated at the height shown by gasket 30 in FIG. 16B, upper portion30A of gasket is above the top of vial 32 resting on ledge 2G of housing2, with ledge 2G being a slightly reduced diameter portion of thevial-side housing tube (2H in FIG. 16B, similar to swab tube 2Adescribed elsewhere herein). Lip 30E of gasket 30 rests on ledge 2G, andfriction interference between upper portion 30A and the wall of vialside housing tube 2H create a seal inhibiting passage of oral fluid. Inthis first position, as swabs/sponges 12A and 12B are compressed as swabassembly 5A is inserted and lowered into housing 2, oral fluid isreleased from swab/sponges 12A and 12B and flows into vial 32 viaopening 32F (and test chamber 2C as previously described via a flowcommunication channel as previously described). Swabs/sponges 12A and12B are further compressed into the downward pressure position, asillustrated in FIGS. 9 and 10. In the second position, as illustrated inFIG. 16C, gasket 30 preferably has upper portion 30A contacting the sidecircumferential wall at the lower end of vial tube 2H, under surface 30Cdownwardly contacting the top circumferential surface of vial 32, andneck surface 30B contacting the inner circumferential wall of the neckportion of vial 32 (on the outside of which via 32 has threads 37engaging corresponding threads of housing 2 to secure vial 32 to housing2).

In accordance with preferred embodiments, gasket 30 is formed of aflexible, but relatively rigid, preferably elastomeric material such asTPE (thermoplastic elastomer) or other polymeric or rubber likematerial. In accordance with preferred embodiments, gasket 30 has adurometer of greater than 50, and more preferably a durometer rating inthe range of 70 to 90. In accordance with certain preferred embodiments,gasket 30 is a flexible material having a durometer of 80+/−5-10%.Applicant has discovered that such a composition of gasket 30 desirablyallows gasket 30 to hold in the first position while having enoughcompression to inhibit oral fluid from flowing around gasket 30 while inthe first position, but yet release, as pressure increases duringdownward movement of the swab assemblies 5A and 5B, at a reasonablepressure to move and traverse down swab tube 2H to the second position,thereby bringing surfaces 30B and 30 C into contact with thecorresponding surfaces of vial 32, and bringing surface 30A into contactwith the circumferential wall of vial tube 2H of housing 2 so as toinhibit oral fluid from flowing around gasket 30 while in the secondposition.

Having gasket 30, housing 2 and vial 32 configured and arranged asillustrated and described herein, certain preferred embodiments utilizeimproved air venting so as to provide reduced back pressure to a userattempting to push swab assemblies 5A and 5B into locked position inhousing 2, and improved fluid extraction efficiency. As illustrated inFIGS. 14 and 15, notch 38 is formed in the lower end portion of threadedwall 37A of housing 2. Notch 38, which may be tapered or contoured,ensures a gap between at least part of the lower end portion of threadedwall 37A of housing 2 (an arrow indicating air flow may be drawn frominside the vial around lower tip 30D and up the neck of vial 32 andaround the threads and out notch 38). As vial 32 is secured onto housing2 using threads 37 of vial 32 and threaded wall 37A of housing 2, theupper lip of vial 32 may contact housing 2 and snug-up to be secure,while notch 38 ensures that there is not an air-tight seal created atthis contact point. Notch 38 thus enables air venting via threads37/threading wall 37A. In accordance with such embodiments, sealing toprevent leaking of oral fluid is achieved via gasket 30 as previouslydescribed. Thus, as swabs/sponges 12A and 12B compress, air is ventedvia notch 38 and threads 37/threaded wall 37A, while fluid flow intovial 32 is facilitated, and an operator experiences less back pressurewhile pushing the overall swab assembly into its final locked positionin housing 2. As will be appreciated, gasket 30 facilitates a linearlymovable, two position valve/sealing implement or member, wherein in afirst (unsealed, venting) position in swab tube 2A, air vents to theoutside of the device, and under pressure of swab compression the gasketlinearly moves/traverses down swab tube 2H to a second(sealed/non-venting) position in swab 2B, where air does not vent to theoutside of the device, and fluid likewise does not escape to the outsideof the device.

As illustrated in FIGS. 12 and 16B and 16C, housing 2 preferablyincludes openings 2F into which protrusions 8A on both sides of swab topcollar 8C engage to lock the overall swab assemblies into housing 2. Asillustrated, protrusions 8A preferably are tapered with an upper ledgeto lock into openings 2F of housing 2, while in other embodiments othershapes of protrusions may be utilized. What is important is that theoverall swab assembly lock into housing 2 so as to dissuade or preventswab assembly removal and prevent/inhibit tampering. Also asillustrated, openings 8E are provided to engage with swab stemspreferably having a similar protrusion to lock swab stems into place andan opening 8F to ensure a corresponding feature of swab assemble top cap8D, such as is illustrated in FIG. 12.

Also as illustrated in FIGS. 16A and 16D, housing 2 preferably has araised (preferably tapered or contoured) center portion 2D on the floorof housing 2 where the lower end of cassette(s) 3AA (FIG. 9) rest(s).Such a raised center portion floor helps channel fluid from cassettetube 21 of housing 2 to the lower ends of the strips inserted incassette(s) 3AA by using gravity to flow oral fluid from the centerregion of test chamber 2C towards its edges where the strip tipspreferably are positioned, thereby facilitating testing of the fluid viathe strips. Housing 2 of FIGS. 9 and 10 includes passage/channel 23 fromtube 21 (similar to swab tube 2B described elsewhere herein) into testchamber 2C of housing 2 containing cassette 3AA and an upper airopening/vent 20 such as previously described in connection with otherpreferred embodiments, Also, as illustrated in FIG. 16A, the floor oftube 21 preferably includes a plurality of raised bumps 2E to helpcompress swab/sponge 12B to facilitate release of oral fluid fromswab/sponge 12B and movement to passage/channel 23 from tube 21 into thecavity containing cassette 3AA. See FIGS. 3 and 4 and relateddescription regarding passage/channel 23 and opening/vent 20.

FIG. 17 illustrates an alternative preferred embodiment of a cassettefor holding test strips having one or more channels, generallyillustrated and described herein as cassette 3AA. It should beunderstood that the present invention contemplates embodiments includingone or two such cassettes 3AA (or similar cassettes) on one or bothsides of housing 2 as will be understood by those of skill in the art.As illustrated in FIG. 17, rightmost channel 3DD (a channel being areceptacle or holding area for a test strip) includes bumps or islands3CC (three such bumps or islands 3CC shown in this exemplary embodiment)that causes the strip to be raised from the bottom floor of channel 3DD.In this manner, the backside of the strip has a spacing from (and thusreduced contact with) the material (preferably plastic) comprisingcassette 3AA. In addition, channel 3DD includes side protrusions 3BB toposition the strip so that the sides of the strip do not contact sidewalls of channel 3DD. Side protrusions 3BB preferably are on oppositesides of channel 3DD but preferably not directly across from each otheras illustrated (in other embodiments, side protrusions 3BB are directlyopposite each other). In this manner, the side edges of the strip have aspacing from and do not contact the side walls of the materialcomprising cassette 3AA. With the combination of bumps/islands 3CC andside protrusions 3BB, the strip more nearly floats in channel 3DD withreduced contact with the material comprising cassette 3AA. As will beunderstood by those of skill in the art, a label generally is providedto cover the strips as positioned in cassette 3AA. Applicants havedetermined that cassette 3AA having one or more (including up to all)channels of cassette 3AA constructed as shown provide improved detectionof substances such as THC. In accordance with certain preferredembodiments, the strip for detecting the presence or absence of THC ispositioned in a channel such as channel 3DD positioned on a rightmost orleftmost channel of cassette 3AA (having a plurality of channels, suchas the 6 channels shown in FIG. 17 or the 7 channels illustrated inFIGS. 1 and 2) so as to more optimally contact oral fluid. Inalternative preferred embodiments, all such channels of cassette 3AAhave bumps/islands 3CC and side protrusions 3BB as is shown for channel3DD of FIG. 17.

In preferred embodiments, cassette 3AA also includes bumps 3EE, whichserve to position cassette 3AA away from front face of housing 2, whichhas been determined to reduce capillary rise of fluid upwards betweencassette 3AA and housing 2. In this embodiment, bumps 3EE may contactthe front face of housing 2, while the main face of cassette 3AA isspaced apart from, and does not contact, the front face of housing 2.Additionally, as illustrated cassette 3AA may optionally have side legshaving a tapered or beveled shape, so as to have a smaller dimension atthe bottom of the legs and a larger dimension at an upward portion ofthe legs. In this manner, the smaller dimension is presented to fluid atthe bottom of test chamber 2C, further reducing the incidence ofcapillary rise or fluid contact with the material of cassette 3AA.

As illustrated in FIG. 19, holding clip 40 is provided so that acomplete swab assembly such as shown in FIG. 8 may be secured by clamp40B, while clamp 40A clamps to vial tube 2H. In this manner, thecomplete swab assembly is secured to the outside of housing 2 so thatthe swab assembly/housing combination may be run through an automatedpouching machine. In accordance with such alternative preferredembodiments, the swab assembly may be packaged in a plastic bag forhygienic considerations, and yet secured to housing 2 in a mannersuitable for automatic pouching.

Applicants' exemplary embodiments expressly include the Single SwabDevice, adapted to leave off the confirmation vial side of the device,including the swab tube and swab assembly in fluid communication withthe confirmation vial. Thus, attributes of housing 2, test chamber 2C,opening/vent 20, channel 23, seals 9B, 11B, 11B′, etc., are desirablyutilized with the Single Swab Device, as well as cassette 3AA and itsvariations as described and shown herein.

As will be understood by those of skill in the art, teachings fromco-pending U.S. application Ser. No. 15/417,905, which has beenincorporated by reference herein, are generally applicable to theexemplary preferred embodiments set forth herein. By way of additionalexplanation and not by way of limitation, certain of such teachings areset forth below.

Analyte Screening

An embodiment of the present invention provides an analyte screeningdevice which includes a rapid screening, lateral flow chromatographicimmunoassay for the simultaneous, qualitative or quantitative detectionof analytes in a fluid sample. For example, without limitation, thefluid sample may be saliva, urine, blood, mucus, water, or fluid extractof a solid or a semi-solid, for example stool or mucus or liquid biopsy.The fluid sample may also be an environmental sample, for example,without limitation, soil, dust, water, plant matter, insect, animalmatter, or a fluid extract of any of the foregoing. The fluid sample mayalso be a food or beverage, for example, without limitation, a liquidbeverage, a liquid-containing food, or a fluid extract of a solid,semi-solid or powdered food or beverage. The fluid sample may alsocontain genomic or proteomic material for testing and analysis.

An embodiment of the invention includes at least one membrane teststrip, in fluid communication with a sample receiving member, able toindicate the presence or absence of at least one analyte above or belowa threshold concentration in the fluid sample using a lateral flowchromatographic assay.

In an embodiment of the invention, the lateral flow chromatographicassay is a competitive assay, in which an analyte in the fluid samplecompetes with a competitor for binding with an anti-analyte antibody.For example, the anti-analyte antibody may be labeled, and thecompetitor may be immobilized in the test region of the membrane teststrip. After the fluid sample reaches the dye region, it encounters thelabeled anti-analyte antibody. If the analyte is present in the fluidsample above a predetermined threshold concentration, the analyte willsaturate the binding sites of the labeled anti-analyte antibody;otherwise, some or the entire labeled anti-analyte antibody remains freeto bind the competitor. As the fluid sample migrates along the membranetest strip by capillary action, it carries the labeled anti-analyteantibody along until it reaches the test region. The test regioncontains the immobilized competitor, which may be the analyte, fragmentsof the analyte, epitopes of the analyte, molecular mimics of theanalyte, anti-idiotypic antibodies, or any other molecule able tocompete with the analyte for binding to the anti-analyte antibody. Ifthe analyte is present above the predetermined threshold concentration,the labeled anti-analyte antibody is saturated and does not bind theimmobilized competitor, resulting in no signal in the test region;otherwise, the anti-analyte antibody is unsaturated and can bind to thecompetitor, resulting in a signal in the test region.

Thus, according to an embodiment of the invention employing acompetitive assay, an analyte-negative fluid sample (containing lowerthan the predetermined concentration of the analyte) will generate aline in the test region due to capture of the labeled anti-analyteantibody, whereas an analyte-positive fluid specimen will not generate acolored line in the test region because the analyte in the fluid samplewill saturate the labeled antibody and thus prevent its capture in thetest region.

In an embodiment of the invention, the lateral flow chromatographicassay is a sandwich assay, in which the analyte must be present for thelabeled anti-analyte antibodies to be captured in the test region. Forexample, the analyte antibody may be a labeled antibody, and a secondanti-analyte antibody may be immobilized in the test region. Forexample, after the fluid sample reaches the dye region, it encountersthe labeled anti-analyte antibody. If the analyte is present in thefluid sample, it will bind at least a fraction of the labeledanti-analyte antibody. As the fluid sample migrates along the membranetest strip by capillary action, it carries the labeled anti-analyteantibody along until it reaches the test region. The test regioncontains an immobilized anti-analyte antibody, which may be reactiveagainst a different epitope of the analyte than the labeled anti-analyteantibody. If the analyte is present in the fluid sample, it forms ascaffold through which the labeled antibodies are immobilized in thetest region. The fraction of the labeled antibodies captured in the testregion is thus determined by the concentration of analyte in the fluidsample. If the analyte of interest is present above a predeterminedthreshold concentration, a sufficient fraction of the labeled antibodiesare captured, resulting in a visible signal in the test region;otherwise, an insufficient fraction of the antibodies are captured andno signal is visible in the test region.

Thus, according to an embodiment of the invention employing a sandwichassay, an analyte-positive fluid specimen will generate a colored linein the test region of the membrane test strip due to the capture of thelabeled antibody in the test region, whereas an analyte-negative fluidsample will not generate a fine in the test region due to failure tocapture the labeled antibody.

Embodiments of the invention include a positive control to indicate thatthe assay has functioned properly and is complete. For example, the dyeregion may include a labeled control protein, including withoutlimitation a labeled control antibody, and the control region of themembrane test strip may contain an immobilized control agent able tocapture the labeled control protein, such as an antibody or a controlanalyte. The control region may be located distal to each test region onthe membrane test strip, such that the fluid sample will encounter eachtest region before encountering the control region. The reaction of thelabeled control protein with the immobilized control agent produces acolored line in the control region, indicating that a proper volume ofthe fluid sample has been added and membrane wicking has occurred, andthe assay has worked properly.

An embodiment of the invention concurrently tests for multiple analytes,for example by employing membrane test strips capable of testingmultiple analytes concurrently (for example, by containing multipleanti-analyte antibodies in the dye region and having multiple compatibletest region), and/or by employing multiple membrane test strips withinthe same apparatus. An embodiment of the invention includes bothmembrane test strips that employ a competitive assay and a sandwichassay, for example on different membrane test strips within the deviceand/or on the same membrane test strip within the device.

Embodiments of the invention may provide quantitative determination ofthe concentration of an analyte that is present in the fluid sample. Forexample, the apparatus may include multiple membrane test strips havingvarying amounts of an anti-analyte antibody, resulting in varyinganalyte sensitivity, such that the concentration of the analyte isindicated by which of the membrane test strips show or fail to show acolored line in the test region.

Antibodies

An embodiment of the invention employs antibodies for the detection ofanalytes. The term “antibody” (Ab) as used herein includes monoclonalantibodies, polyclonal antibodies, multispecific antibodies (for examplebispecific antibodies), and antibody fragments, so long as they exhibitthe desired activity. The term “monoclonal antibody” as used hereinrefers to an antibody obtained from a population of substantiallyhomogeneous antibodies, that is, the individual antibodies comprisingthe population are identical except for possible naturally occurringmutations that may be present in minor amounts.

The terms “labeled antibody” and “labeled control protein” refer to anantibody or protein that is conjugated directly or indirectly to alabel. The label is a detectable compound or composition that may bedetectable by itself, Including without limitation a dye, colloidalmetal (including without limitation colloidal gold), radioisotope, orfluorescent compound, or, in the case of an enzymatic label, maycatalyze chemical alteration of a substrate compound or compositionwhich is detectable, or any combination of the foregoing.

Analytes

According to an embodiment of the invention, the apparatus includes adevice for testing a fluid sample for the presence of analytes. Thepresent invention contemplates testing for any analyte. Withoutlimitation, analytes that may be tested for include drugs of abuse ortheir metabolites, analytes indicating the presence of an infectiousagent or product of an infectious agent, allergen, pollutant, toxin,contaminant, analyte with diagnostic or medical value, antibody againstany of the foregoing, and any combination thereof.

According to an embodiment of the invention, analytes that may be testedfor include drugs of abuse and their metabolites, including withoutlimitation 7-acetaminoclonazepam, alkyl nitrites,alpha-hydroxyalprazolam, alprazolam,2-amino-2′-chloro-5-nitrobenzophenone, 7-aminoclonazepam,7-aminonitrazepam, amitriptyline, amobarbital, amoxapine, amphetamine,anabolid steroids, androgen, androstadienone, aprobarbital, atropine,barbiturates, benzodiazepines, benzoylecgonine, benzylpiperazine,boldenone undecylenate, 4-bromo-2,5-dimethoxyphenethylamine, bovinegrowth hormone, butabarbital, butalbital, butripryline,4-chlordehydromethyltestosterone, chloroform, clomipramine, clonazepam,clostebol, cocaethylene, cocaine, codeine, codeine-6-glucuronide,cotinine, dehydroepiandrosterone, desipramine, desmethyldiazepam,desoxymethyltestosterone, dexmethylphenidate, dextroamphetamine,dextromethorphan, dextropropoxyphene, dextrorphan,2,5-diamino-2′-chlorobenzophenone, diamorphine, diazepam, dibenzepin,dihydrotestosterone, dimenhydrinate,2,5-dimethoxy-4-(n)-propylthiophenethylamine,2,5-dimethoxy-4-ethylphenethylamine, 2,5-dimethoxy-4-iodophenethylamine,dimethyl ether, dimethyltryptamine, dimethyltryptamine, diphenhydraminehydrochloride, dosulepin hydrochloride, dothiepin hydrochloride,doxepin, drostanolone, ecgonine, ecgonine methyl ester, ephedrine,ergine, estren, 5-estrogen,ethyl-5-(1′-methyl-3′-carboxypropyl)-2-thiobarbituric acid,5-ethyl-5-(1-′-methyl-3′-hydroxybutyl)-2-thiobarbituric acid,ethylestrenol, ethylphenidate, fentanyl, flunitrazepam, fluoxymesterone,furazabol, gamma-hydroxybutyrate, 1-(beta-D-glucopyranosyl) amobarbital,growth hormone, heroine, hexabarbital, human to chorionic gonadotropin,human growth hormone, hydrocodone, hydromorphone,(+)-3-hydroxy-N-methylmorphinan, 3-hydroxy clonazepam,11-hydroxy-tetrahydrocannabinol (11-hydroxy-THC), 3′-hydroxyamobarbital,p-hydroxyamphetamine, p-hydroxynorophedrine, imipramine, iprindole,kava, katamine, levomethylphenidate, iofepramine, lorazepam,lorazepam-glucuronide, lysergic acid diethylamide, meperidine,mescaline, mestanolone, mesterolone, meta-chlorophenylpiperazine,methadone, methamphetamine, methandrostenolone, methcathinone,3,4-methylenedioxyamphetamine, methanolone, methanolone enanthate,methylenedioxymethamphelamine (ecstacy), methylphenidate,methylphenobarbital, methyl testosterone, mibolerone, (+)-3-morphinan,morphine, nandrolone, nicotine, nitrazepam, N-methyl-diethanciamine,norbolethone, norcodeine, norethandrolone, norketamine, nortriptyline,opiates, opipramol, opium, oxabolone opionate, oxandrolone, oxazepam,oxycodone, oxymetholone, oxymorphone, pentobarbital, phencyclidine,phenethylamines, phenobarbital, 4-phenyl-4-(1-piperidinyl)-cyclohexanol,1-phenyl-1-cyclohexene, phenylacetone,5-[N-(1-phenylcyclohexyl)]-aminopentanoic acid,1-(1-phenylcyclohexyl)-4-hydroxypiperidine, piperidine, protriptyline,psilocin, psilocybin, quinbolone, salvinorin A, scopolamine,secobarbital, sodium thiopental, stanozolol, telbutal, temazepam,testosterone, testosterone proprionate, tetrahydrocannabinol (THC),THC-COOH, tetrahydrogestrinone, toluene, trenbolone, tricyclicantidepressant, 3-trifluoromethylphenylpiperazine, trimipramine,tryptamines, or any combination thereof. The minimum concentration levelat which the presence of any particular drug or metabolite is detachedmay be determined by various industry minimum standards, such as, forexample, the National Institute on Drug Abuse (NIDA), the SubstanceAbuse & Mental Health Services Administration (SAMHSA), and the WorldHealth Organization (WHO).

According to an embodiment of the invention, analytes that may be testedfor include infectious agent or the products of an infectious agent,including without limitation Acanthamoeba, aflatoxin, alimentarymycotoxlcoses, altertoxin, amoeba, Anisakis, Ascaris lumbricoides,Bacillus arthracis, Bacillus cereus or its toxin, bacteria, bovinespongiform encephalopathy prioris, Brucella, Caliciviridae,Calymmatobacterium granulomatis, Campylobacter, Campylobacter jejuni,Candida, Candida albicans, Cephalosporium, Chlamydia trachomatis,chronic wasting disease prions, Citrinin, Clostridium botulinum or itstoxin, Clostridium perfringens, Corynebacterium ulcerans, Coxieliaburnetil, Creutzieldt-Jakob disease prions, Cryptococcus neoformans,Cryptosporidium, Cryptosporidium parvum Cycloplazonic acid, Cyclosperacayetanensis, Cytochaiasin, Cytomegalovirus, Diphyilobothrium,Escherichia Coli, Ebola, endotoxin, Entamceba histolytica, Enterovirus,Ergopeptine alkaloid, Ergot alkaloid, Ergotamine, Escherichia coli O157,Eustrongylides, Fasciola hepatica, fatal familial insomnia prions,flatworm, Francisella tularensis, Fumitremorgen B.sub.1 Fumonisin,Fusarium, Fusarochromanone, genital warts,Gerstmann-Straussler-Scheinker syndrome prions, Giardia, Giardialamblia, Granuloma inguinale, H7 enterohemorrhagic, Haemophilus ducreyl,Helicobacter pylori, Hepatitis, Hepatitis A, Hepatitis B, Hepatitis C,Hepatitis D, Hepatitis E, Hepatitis E, herpes simplex virus, Histoplasmacapsulatum, HIV, HIV-1, HIV-2, human papillomavirus, influenza, Kaposi'ssarcoma-associated herpesvirus, Kojic acid, kuru prions, Listeriamonocytogenes, Lolitrem alkaloids, marburg virus, Methicillin-resistantStaphylococcus aureus or its toxin, molluscum, Moniliformin,mononucleosis, mycobacteria, Mycobacterium tuberculosis, Mycoplasma,Mycoplasma hominis, Mycotoxins, Myrothecium, Nanophyetus, Neisseriagonorrhosae, nematode, Nivalenol, Norovirus, Oohratoxins, Oosporeine,parasite, Patulin, Paxilline, Penitrem A, Phomopsins, Plasmodium,Platyhelminthes, Plesiomonas shigelloides, Pneumococcus, Pneumocystisjirovecii, prions, protozoa, rhinovirus, Rotavirus, Salmonella,Sarcocystis hominis, Sarcocystis sulhominis, scraple prions, sexuallytransmitted disease, Shigella, Shigella, Sporidesmin A, Stachybotrys,Staphylococcus aureus or its toxin, Sterigmatocystin, Streptococcus,Streptococcus pneumoniae, Streptococcus pyogenes, Taenia saginata,Taenia solium, tapeworm, Tenia solium, Tinea, Toxoplasma gondii,Tremorgenic mycotoxins, Treponema palidum, Trichinella spiralis,Trichoderma, Trichomonas vaginalis, Trichothecene, Trichuris trichlura,Typanosoma cruzi, Ureaplasma urealyticum, Verrucosidin, Varruculogen,Vibrio cholerae non-O1, Vibrio cholerae O1, Vibrio-parahaemolyticus,Vibrio vulnificus, viruses, yeast infections, Yersinia enterocolitica,Yersinia pseudotuberculosis, Zearalenois, Zearalenone, antibodiesagainst any of the foregoing, or any combination thereof.

According to an embodiment of the invention, the analytes to be testedfor include allergens, including without limitation aesculus, aider,almonds, animal products, arternisia vulgaris, beans, bet sting venom,birch, calyx, cat dander, celeriac, celery, chenopodium album,cockroach, corn, dander, dong dander, drugs, dust mite excretion, eggalbumen, eggs, to Fei d 1 protein, fruit, fur, grass, hazel, hornbeam,insect stings, latex, legumes, local anaesthetics, maize, metal, milk,mold spores, mosquito saliva, mouse dander, nettle, olea, peanuts, peas,pecans, penicillin, Plant pollens, plantago, platanus, poplar, pumpkin,ragweed, rat dander, ryegrass, salicylates, seafood, sesame, sorrel,soy, soybeans, sulfonamides, tilia, timothy-grass, tree nuts, trees,wasp sting venom, weeds, wheat, willow, antibodies against any of theforegoing, or any combination thereof.

According to an embodiment of the invention, the analytes to be testedfor include pollutants, toxins, and contaminants, including withoutlimitation 1,2-Dibromoethane, acrylamide, aldehydes, arsenic, artificialgrowth hormone, asbestos, benzene, benzopyrene, carcinogens,dichloro-diphenyl-trichloroethane, formaldehyde, kepone, lead, mercury,methylmercury, nitrosamines, N-nitroso-N-methylurea, organochlorineinsecticides, pesticides, polychlorinated biphenyls, polychlorinateddibenzofurans, polychlorinated dibenzo-p-dloxins, recombinant bovinegrowth hormone, recombinant bovine somatotropin, toluene, vinylchloride, antibodies against any of the foregoing, or any combinationthereof.

According to an embodiment of the invention, the analytes to be testedfor include analytes with diagnostic or medical value, including withoutlimitation acid phosphatase, active-B12, AFP, Alanine Aminotransferase,Alanine Aminotransferase, Albumin, Albumin BCG, Albumin BCP, AlkalinePhosphatase, Alpha-1 Antitrypsin, Alpha-1 Glycoprotein, Amikacin,Ammonia, Amylase, Anti-CCP, Anti-Tg, Anti-TPO, Apolipoprotein A1,Apolipoprotein B, ASO, Asparate Aminotransferase, AspartateAminotransferase, B12, Beta2 Microglobulin, Beta2 Microglobulin, BNP, CA125, CA 125 II, CA 15-3, CA 19-9 XR, Calcium, Carbamazepine, CarbonDioxide, CEA, Ceruloplasmin, Cholesterol, CK-MB, Complement C3,Complement C4, Cortisol, C-Peptide, C-Reactive Protein, Creatine Kinase,Creatinine, CRP Vario, Cyclosporine, Cyclosporine and Metabolite-WholeBlood, Cyclosporine Monoclonal-Whole Blood, D-Dimer, DHEA-S, Digitoxin,Digoxin, Digoxin, Digoxin II, Digoxin III, Direct Billirubin, DirectLDL, Estradiol, Ferritin, FLM II, Folate, Free Carbamazepine, FreePhenytoin, Free PSA, Free T3, Free T4, Free Valproic acid, FSH,Gamma-Glutamyl Transferase, Gentamicin, Glucose, Glycated Hemoglobin,Haptoglobin, hCG, Hemoglobin, Homocysteine, ICT CI-, IGFBP-1,Immunoglobulin, Immunoglobulin A, Immunoglobulin E, immunoglobulin G,Immunoglobulin M, Insulin, Intact PTH, Iron, K+, Kappa Light Chain,Lactate Dehyrogenase, Lactic acid, Lambda Light Chain, LH, Lidocaine,Lipase, Lithium, Lp, magnesium, metabolites, Methotrexate II,Microalbumin, MPO, Myoglobin, Na+, N-Acetyl-procainamide, neonatalBillirubin, NGAL, P-Amylase, Pepsinogen I, Pepsinogen II, Phenobarbital,Phenytoin, Phosphorus, Prealbumin Procainamide, Progesterone, Prolactin,Quinidine, Rheumatoid Factor, SHBG, Sirollmus, STAT CK-MB, T4,Tacrolimus, Tacrolimus II, Testosterone, Tg, Theophylline, TheophyllineII, TIBC, TIMP-1, Tobramycin, Total Billirubin, Total Estriol, TotalProtein, Total PSA, Total T3, Total T4, Transferrin, Triglycerides,Troponin-I, Troponin-I ADV, TSH, T-Uptake, UIBC, Ultra HDL, UreaNitrogen, Uric Acid, Urine/CSF Protein, Valproic Acid, Vancomycin,Vancomycin II, Vitamin D, antibodies against any of the foregoing, orany combination thereof

Receiving Member

According to an embodiment or the invention, the apparatus includes areceiving member, having an opening to receive a fluid sample, Forexample, the receiving member may be dimensioned to receive a fluidcollector. In an embodiment of the invention, the receiving member maybe in fluid communication with other components of the apparatus, forexample at least one membrane test strip, sample retention member,and/or an Immunoassay-based fingerprint acquisition pad, throughchannels, for example tubes, piping, channels molded or carved into theapparatus, or any other suitable structure, made of any suitablematerial, for example plastic, ceramic, metal, glass, wood, rubber,polymer, fiber-reinforced polymer, or any combination thereof.

According to an embodiment of the invention, the channel or channelsproviding fluid communication between the components may have differingflow resistance, for example having channels, channel segments, oropenings, that are narrower, wider, longer, or shorter than others,and/or having fluid paths with varying amounts of vertical rise or drop,such that the fluid channels within the device have varying degrees offlow resistance. For example, the channel that provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip may have greater flow resistance than the at leastone channel that provides the fluid communication of the samplereceiving member with the sample retention member, to ensure that aportion of the fluid sample is collected in the sample retention member.

In an embodiment of the invention, a single channel having multipleopenings may connect the receiving member to each of the components ofthe apparatus with which it is in fluid communication, for example theat least one membrane test strip, sample retention member, and/orimmunoassay-based fingerprint acquisition pad.

In an embodiment of the invention, the receiving member may include twoor more chambers for receipt of a multi-pronged fluid collector,including but not limited to a dual-swab fluid collector. Components ofthe apparatus may be solely connected to one of the multiple chambers.For example, in a two chamber embodiment, one chamber may be solelyconnected to a sample retention member to ensure that a portion of thefluid sample is collected and stored without interaction of the othercomponents of the apparatus.

An embodiment of the invention may accommodate fluids of varyingviscosity, for example water, saliva, urine, blood, and liquidsassociated with genomics and proteomics.

Generally, this is accomplished by varying the diameter of the channelor channels that provide the fluid communication of the sample receivingmember with the other components of the apparatus, for example providinga wider channel diameter to accommodate a more viscous fluid.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of water provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of water provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of urine provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of urine provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of saliva provides thefluid communication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of saliva provides thefluid communication of the sample receiving member with the sampleretention member.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of blood provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of blood provides the fluidcommunication of the sample receiving member with the sample retentionmember. In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of mucus provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of mucus provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of liquid associated withcell separation provides the fluid communication of the sample receivingmember with the at least one membrane test strip and at least onechannel dimensioned to be compatible with a fluid having the viscosityof liquid associated with cell separation provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of liquid biopsy, such asproteomics or genomics, provides the fluid communication of the samplereceiving member with the at least one membrane test strip and at leastone channel dimensioned to be compatible with a fluid having theviscosity of liquid biopsy provides the fluid communication of thesample receiving member with the sample retention member. Proteomics isthe study of proteins. Genomics is a branch of molecular biologyconcerned with the structure, function, evolution, and mapping ofgenomes.

In an embodiment of the invention, the receiving member may have aninner surface, for example a lower surface, that an absorbent material,such as an absorbent material present in a fluid collector, may becompressed against, thereby expelling the fluid sample from theabsorbent material. For example, the absorbent material may becompressed directly between a compression member present on the fluidcollector and the lower surface of the receiving member or the receivingmember may provide structural support to facilitate compression of theabsorbent material between a compression member and the housing that atleast partially surrounds the absorbent material.

Sample Retention Member

According to an embodiment of the invention, the apparatus includes asample retention member. The sample retention member may be used tosecurely contain a portion of the fluid sample, such as a split sample.The retained portion of the fluid sample may be used for furthertesting, for example for confirmation of a test result obtained using amembrane test strip, or to test for the presence or absence of otheranalytes in the fluid sample. The retained portion of the fluid samplemay also be used for confirmation of the test subject's identity throughanalysis of a distinguishing feature thereof, including withoutlimitation DNA, cells, proteomics, metals, and liquid biopsy.

According to one embodiment of the invention, the sample retentionmember includes an absorbent material, for example a pad or sponge, ormade of woven or non-woven fibrous or fabric-like material, for examplecellulose or a cellulose derivative, cotton, hydrophilic foam, woodpulp, polyvinyl alcohol fibers, or any combination thereof. The sampleretention member may include an absorbent material that is part of thesample collection apparatus. The absorbent material may be surrounded bya barrier, such as a liquid-impermeable material, including withoutlimitation plastic, ceramic, metal, glass, wood, rubber, polymer,fiber-reinforced polymer, or any combination thereof, to prevent theretained sample from leaking or evaporating. In an embodiment of theinvention, the absorbent material may be removably attached to theapparatus to facilitate retrieval of the retained fluid sample. In anembodiment of the invention, the absorbent material may be accessedusing a needle, for example by piercing a barrier surrounding theabsorbent material. The retained sample may then be removed, forexample, into a syringe attached to a needle, by means of withdrawal ofthe syringe to create suction.

According to an embodiment of the invention, the sample retention memberincludes a storage container defining a volume for storage of the fluidsample. In one embodiment of the invention, the sample retention membermay be a vial made from a breakable or nearly unbreakable material,including without limitation glass, plastic, ceramic, metal, metal foil,wood, rubber, polymer, fiber-reinforced polymer, or any combinationthereof. In an embodiment of the invention, the storage container may beaccessed using a needle to pierce the wall of the storage container. Forexample, the storage container may include a pierceable member, such asa region of decreased wall thickness, and/or made of a soft, pierceable,or breakable material, including without limitation plastic, ceramic,metal, glass, metal foil, wood, rubber, polymer, fiber-reinforcedpolymer, or any combination thereof, that may be pierced. The retainedsample may then be removed, for example, into a syringe attached to aneedle, by means of withdrawal of the syringe to create suction. In anembodiment of the invention, the storage container may be removablyattached to the apparatus, including without limitation, through a lineof weakness that may allow the storage container to be broken free formthe apparatus, through a threaded connection mechanism between thesample retention member and the fluid sample testing device, or througha twisting lock connection mechanism between the sample retention memberand the fluid sample testing device.

According to an embodiment of the invention, the removable sampleretention member may be linked to or coded consistently with the fluidsample testing device, including but not limited to, identical orrelated identification or serial numbers on both the sample retentionmember and the fluid sample testing device, identical or related barcode information on both the sample retention member and the fluidsample testing device, and the inclusion of radio frequencyidentification devices (RFID) on the sample retention member or thesample retention member and the fluid sample testing device. RFIDincorporates the use of electromagnetic or electrostatic coupling in theradio frequency (RF) portion of the electromagnetic spectrum uniquelyidentify an object; such unique identification information may beinformation specific to the sample provider or information unique to thefluid sample testing device.

According to an embodiment of the invention, the sample retention membercontains substances that facilitate a further use of the sample,including without limitation preservatives of stabilizers able topreserve sample integrity, for example substances able to inhibitmicrobial growth, kill microbes, prevent sample leakage, prevent sampleevaporation, inhibit chemical or enzymatic degradation of substances inthe sample, support survival of cells or other microbes in the sample,or any combination thereof.

According to an embodiment of the invention, the sample retention membermay be bonded to a fingerprint acquisition pad. For example, such a bondmay provide a safeguard against dissociation of the retained sample fromthe fingerprint.

According to an embodiment of the invention, the sample retention membermay be in fluid contact solely with the sample receiving member and maynot have any fluid contact with any other component of the apparatus.The retained fluid sample may be used for further confirmation testing,including without limitation gas chromatography, liquid chromatography,mass spectrometry, liquid or gas chromatography with tandem massspectrometry, polymerase chain reaction, DNA sequencing, Enzyme-LinkedImmunoSorbent Assay, Western Blotting, culturing for growth, or anycombination thereof, using the retained fluid sample.

Fluid Collector

In embodiment of the apparatus comprises a fluid collector forcollecting a fluid sample. The present invention contemplates collectinga sample from a specific subject, such as a human subject, or testingenvironmental samples, such as testing air, water, soil, or some othersubstance, or a food or beverage, or a liquid extract of any of theforegoing for example, without limitation. The fluid collector isoperative associated with the apparatus. The fluid collector may beremovably associated with the apparatus/affixed to the apparatus, orcomprise multiple units of which one or more is affixed or removablyassociated with the apparatus.

In an embodiment of the invention, the fluid collector includes anabsorbent material or swab capable of absorbing a desired quantity of afluid sample. The absorbent material may be made of any suitablematerial known to a person in the art, for example, without limitation,a pad or sponge, or woven or non-woven fibrous or fabric-like material,including without limitation cellulose or a cellulose derivative,cotton, hydrophilic foam, wood pulp, polyvinyl alcohol fibers, or anycombination thereof. In an embodiment of the invention, the fluidcollector includes a compression member, able to compress the absorbentmaterial, that may be used to expel air from the absorbent materialprior to collection of the fluid sample and/or encourage the fluidsample to flow into the absorbent material by creating suction as thecompressed absorbent material returns to the uncompressed state. Acompression member may also be used, for example, to compress theabsorbent material and expel a fluid sample contained therein.

In one embodiment of the invention, the fluid collector includesmultiple collection swabs. For example, a two-prong fluid collector withdual swabs may be implemented to collect the sample. In one embodiment,each swab of a multi-swab fluid collector may be selected based upon thespecific swab collection characteristics. For example, in a dual-swabfluid collector, each swab may contain a material to assist in thecollection of different samples such as the collection of different cellmaterial.

A sufficiency indicator on the collector is contemplated. For examplewithout limitation, a color indicator may either appear or disappearwhen a sufficient sample has been collected, for example when asufficient volume has been absorbed to reach the location in theabsorbent material where the sufficiency indicator is disposed.According to an embodiment of the invention, the sufficiency indicatormay be operatively associated with the absorbent material and mayprotected from direct contact with the source of the fluid sample by abarrier, such as a transparent barrier, for example plastic or glass,such that the fluid sample will only reach the sufficiency indicator bypassing into the absorbent material.

The sufficiency indicator color may be in the shape of a word or symbolthat appears or disappears when a sufficient sample has been collected.For example, the sufficiency indicator may a diffusible dye, whereindilution of the dye by the fluid sample causes a color to disappear,indicating that a sample of sufficient volume has been collected. In anembodiment of the invention, a combination of a non-diffusible anddiffusible dye may be used together, such that the non-diffusible dyeremains and provides an informative message when the diffusible dyedisappears, for example the diffusible dye may form the letters “in” inthe word “insufficient” such that the non-diffusible dye remains andforms the word “sufficient” when a sufficient sample has been collected.

The sufficiency indicator may be a pH-sensitive substance that changescolor when the sample is encountered. For example, multiple pH sensitiveindicators responding to different pH values may be preset, such that acolor change is observed whether the sample is acidic, basic, orneutral. According to an embodiment of the invention, a pH-changingsubstance, such as an acid or base, may be disposed within the absorbentmaterial, such that the sample will be of the correct pH to elicit thedesired color change in the sufficiency indicator.

A closure member may be used. The closure member is capable of sealingthe open end of a sample receiving member when the fluid collector isinserted into the open end of a sample receiving member. For example,the closure member may be dimensioned to fit closely in the opening inthe open end of the receiving member, and the closure member or the openend of the receiving member may include a compressible material,including without limitation natural rubber such as vulcanized rubber,synthetic rubber such as neoprene or nitrite rubber, plastic, ceramic,or any combination thereof, disposed at the interface between theclosure member and the opening in the open end of the sample receivingmember, capable of creating a seal, such as an airtight or a watertightseal, when the sample receiving member receives the fluid collector.

After the fluid collector has been inserted into the sample receivingmember, a device for securing the fluid collector within the samplereceiving member is contemplated. The means for securing may preventremoval of the fluid collector from the sample receiving member after ithas been inserted therein. The means for securing the fluid collectorwithin the sample receiving member may include at least one projectionextending from the fluid collector that cooperates with the at least oneprojection located on the inner surface of the sample receiving member,where such projections may include for example at least one locking taband/or at least one annular ring. According to an embodiment of theinvention, a closure member on the fluid collector may form asufficiently secure closure as to constitute means for securing thefluid collector within the sample receiving member.

The sample receiving member may also include a tamper-evident seal, suchthat attempting to tamper with the contents of the apparatus will resultin a visual indicator, for example by tears or breakage visible in animprinted seal, for example tape or adhesive-backed foil havingcharacters, symbols or a signature on a surface. Such a tamper-evidentseal may be placed on the apparatus before its use, to create a visualconfirmation that the intents of the apparatus have not been altered viathe open end of the receiving member prior to testing, or after its use,to create a visual confirmation that the contents of the apparatus havenot been altered via the open end of the receiving member subsequent totesting. According to an embodiment of the invention, the means forsecuring the fluid collector within the sample receiving member mayconstitute a tamper evident seal, in that attempted removal of the fluidcollector from the sample receiving member after it has been insertedtherein may result in visible damage to the apparatus.

According to an embodiment of the invention, the fluid collectorincludes a handle, for example made of wood, plastic, ceramic, or metal,and disposed, for example, at the end distal to the absorbent material.The handle may be removably attached, for example through aninterference fit, adhesive, glue, or epoxy, that breaks or separateswhen the handle is twisted and/or pulled, or by a structure that allowsthe handle to be broken away, for example, a line of weakness.

The fluid collector may include a housing that at least partiallysurrounds the absorbent material. The housing may have multiple openingsto allow the fluid sample to be absorbed by and expressed from theabsorbent material. The openings in the housing may contain filtrationmembers able to strain particulates from the fluid sample, resulting inreduction of the number of particulates that enter the absorbentmaterial. The fluid collector may include a compression member able tocompress the absorbent material against the housing. For example, thehousing may be slideably coupled to a compression member with theabsorbent material disposed between the compression member and an innersurface of the housing, such that the absorbent material may becompressed by movement of the compression member towards an innersurface of the housing. An embodiment of the invention includes meansfor securing the absorbent material in the compressed state, includingwithout limitation cooperating threads, projections, and/or groovesoperatively associated with the compression member and the housing. Theabsorbent material may be released from the compressed state before,concurrently with, or after encounter with the fluid sample,facilitating entry of the fluid sample into the absorbent material asthe absorbent material returns to the relaxed state, creating suction.For example, the absorbent material may be operatively associated with aspring, such that compression of the absorbent material results incompression of the spring, and when compression is released the springassists return of the absorbent material to the uncompressed state.

In an embodiment of the invention, the fluid collector is operativelyassociated with the lid of a fluid container including withoutlimitation a urine cup. For example, the absorbent material may bedisposed on the inner side of the lid, such that attachment of the lidto the fluid container results in contact between the absorbent materialand a fluid sample. In certain embodiments of the invention, a portionof the fluid collector including the lid may be removably associatedwith a portion of the fluid collector including the absorbent material,allowing the absorbent material to be separated from the lid. Theoperative association of the fluid collector with the lid may includemeans for arresting the rotation of part of the fluid collector relativeto the lid, including without limitation cooperating projections presenton one member and grooves or slots present on the other member, forexample to facilitate release of means by which the absorbent materialis fixed in the compressed state.

Saliva Producing Substances

Use of a saliva producing substance is contemplated by the presentinvention. Saliva producing substances elicit or increase salivaproduction in the test subject. For example, without limitation, thesaliva producing substance may sugars, salts, acids, or any combinationthereof. In an embodiment of the invention, the saliva producingsubstance may be associated with a fluid collector, for example locatedon or in the absorbent material or the housing. In an embodiment of theinvention, the saliva producing substance may be separated from thefluid collector, for example in the form of a gum, candy, or powder, foradministration to the test subject before, during or after the fluidcollector is inserted into the test subject's mouth.

For example, without limitation, the sugar may be a monosaccharide, adisaccharide, a trisaccharide, an oligosaccharide, a polysaccharide,acarbose, allose, altrose, amylose, arabinose, calibiose, cyclodextrin,alph-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin, deoxyglucose,dextrin, dihydroxyacetone, erythrose, erythrulose, ficoli,fructo-oligosaccharides, fructose, galacto-oligosaccharides, galactose,gentiobiose, glucoasmine, glucose, glyceraldehyde, glycogen, gulosse,idose, inositol, inulin, isomaltose, lactose, lyxose, maltose,maltosyl-cyclodextrin, malt-trifose, mannan-oligosaccharides,mannoheptulose, marinose, melexltose, monnitol, psiccae, raffinose,ribitol, ribose, ribulose, sedoheptulose, sorbitol, sorbose, sucrose,tagatose, talose, threose, trehalose, xylose, xylulose, or anycombination thereof.

For example, without limitation, the salt may an inorganic salt, organicsalt, acid salt, alkali salt, neutral salt, or amino acid salt, or anycombination thereof. The salt may include a cation and an anion, forexample without limitation thereto, the cation may be aluminum,ammonium, barium, beryilium, calcium, cesiu, chromium(II),chromium(III), chromium(IV), cobalt(II), cobalt(III), copper(I),copper(II), copper(III), gallium, helium, hydrogen, hydronium, iron(II),iron(III), lead(II), lead(IV), lithium, magnesium, manganese(II),manganese(III), manganese(IV), manganese(VII), nickel(II), nickel(III),nitronium, potassium, pyridinium, silver, sodium, strontium, tin(II),tin(IV), zinc, or any combination thereof, and an anion may be acetate,amide, tartrate, borate, bromate, bomide, carbonate, chlorate, chloride,chlorile, chromate, citrate, cyanate, dichormate, dihydrogen phosphate,fluide, formate, glutamate, hydride, hydrogen carbonate, hydrogenoxalate, hydrogen phosphate, hydrogen sulfate, hydrogen sulfite,hydroxide, hypobromite, hypochlorite, lodate, iodide, nitrate, nitride,nitrite, oxalate, oxide, perchlorate, permanganate, peroxide, phosphate,phosphide, phosphite, pyrophosphate, sulfate, sulfide, sulfite,telluride, thiocyanate, thiosulfate, or any combination thereof. Forexample, according to an embodiment of the invention, the salt may besodium chloride or potassium chloride.

The acid may be any suitable acid known to a person skilled in the art,for example acetic acid, acrylic acid, adipic acid, alginic acid,alkanesulfonic acid, amino acid, asorbic acid, benzoic acid, boric acid,butyric acid, carbonic acid, carboxylic acid, citrio acid, fattys acid,folic acid, formic acid, fumaric acid, gluconic acid, hdyriodic acid,hydrobromic acid, hydrochloric acid, hydroquinosulfonic acid,isoascorbic acid, lactic acid, maleic acid, malio acid, malonic acid,methanesulfonic acid, nitric acid, oxalic acid, p-toluenesulfonic acid,para-bromophenylsulfonic acid, phosphoric acid, propionic acid,salicyclic acid, stearic acid, succinic acid, sulfuric acid, tannicacid, tartaric acid, thioglycolic acid, toluenesulfonic acid, uric acid,or any combination thereof.

Fingerprint Identification

An embodiment of the present invention includes a fingerprint pad toprovide identification of an individual associated with the test, suchas the test subject, test administrator, and/or one or more witnesses.The fingerprint pad may employ any suitable fingerprinting methodology,for example, without limitation, ink-based, immunoassay-based,electronic, semi-inkless, or inkless. In an embodiment of the invention,the fingerprint pad may be able to collect multiple fingerprints, forexample having multiple fingerprint pads, having one fingerprint pad ofsufficient size to accommodate multiple fingerprints, or having anelectronic fingerprint pad.

The fingerprint pad may be an ink-based fingerprint pad. An embodimentof the invention includes a dispenser able to dispense an ink that canelicit a signal in the ink-based fingerprint pad. The fingerprint padmay also be inkless or semi-inkless, for example requiring no ink orcompatible with an activator that appears transparent on the subject'sskin, is readily cleaned off the subject's skin, or readily disappears,for example, when the subject's hands are rubbed together. According toan embodiment of the invention, the inkless fingerprint pad may beimmunoassay-based, for example as described within U.S. Pat. No.6,352,663 to Raouf A. Guirguis, issued Mar. 5, 2002 (the “'863 patent”),and U.S. Pat. No. 5,244,815 to Raouf A. Guirguis, issued Sep. 14, 1993(the “'815 patent”), which are incorporated herein by reference in theirentirety. The immunoassay-based fingerprint pad may or may not be influid communication with a sample receiving member. Other embodiments ofthe invention may incorporate various features of the embodimentsdisclosed within the '863 and '815 patents. In embodiment of theinvention having an inkless or semi-inkless fingerprint pad thatrequires an activator to elicit a signal, the apparatus may also includea dispenser to dispense the activator. According to an embodiment of theinvention, the fingerprint pad may have a surface, such as an absorbentor adhesive surface, able to gather sweat, oils, and/or skin cells whena finger is pressed against it, that may require further processing topermit clear visualization of the fingerprint.

According to an embodiment of the invention, an inkless fingerprint padmay be an electronic fingerprint pad, including without limitation anoptical scan fingerprint reader or a solid-state fingerprint reader. Anembodiment of the invention includes a memory element, including withoutlimitation volatile or non-volatile memory, for example a hard disk,floppy disk, magnetic tape, optical disk, flash memory, holographicmemory, EEPROM, RAM, DRAM, SDRAM, or SRAM coupled to the fingerprint padfor storage of one or more fingerprints. According to an embodiment ofthe invention, the electronic fingerprint pads may have electricallycharged surface elements, wherein portions of the surface areelectrically discharged upon contact with the finger surface, such asthe ridges of the finger surface, such that the fingerprint is recordedin the pattern of discharged elements, whereby the fingerprint patternmay be stably stored within the surface for a time after it is createduntil it is read, for example through connection of the apparatus withan external device, including without limitation a base station. Anembodiment of the invention include means of transmission of thecaptured fingerprint, for example to an external device or network,including without limitation through a hard-wired connection, forexample employing wires, cables, or a docking station or dockingconnector, for employing a connection including without limitation USB,IEEE 1394, serial, parallel, or SCSI, or a wireless connection, forexample employing infrared, RF, IEEE 802.11, Bluetooth, IEEE 802.15, orWi-Fi.

In an embodiment of the invention, a cover encloses the fingerprintacquisition pad. The cover may be secured using various mechanisms, forexample, without limitation, a tab-and-slot connector, latch, springlatch, adhesive tape, or security tape. The cover may be secured priorto fingerprint acquisition and/or after fingerprint acquisition.

Although the invention is described herein with reference to specificembodiments, various modifications and changes can be made withoutdeparting from the scope of the invention as set forth in the claimsbelow. The combination of embodiments is expressly anticipated, unlessthe embodiments and specifically mutually exclusive. A claimed inventionmay include multiple embodiments as disclosed herein. Accordingly, thespecification and figures are to be regarded in an illustrative ratherthan a restrictive sense, and all such modifications are intended to beincluded within the scope of the invention. Any benefits, advantages, orsolutions to problems that are described herein with regard to specificembodiments are not intended to be construed as a critical, required, oressential feature or element of any or all the claims.

From time-to-time, the invention is described herein in terms of theseexample embodiments. Description in terms of these embodiments isprovided to allow the various features and embodiments of the inventionto be portrayed in the context of an exemplary application. Afterreading this description, it will become apparent to one of ordinaryskill in the art how the invention can be implemented in different andalternative environments. Unless defined otherwise, all technical andscientific terms used herein have the same meaning as is commonlyunderstood by one of ordinary skill in the art to which this inventionbelongs.

The preceding discussion is presented to enable a person skilled in theart to make and use the invention. The general principles describedherein may be applied to embodiments and applications other than thosedetailed below without departing from the spirit and scope of theinvention as defined by the appended claims. The invention is notintended to be limited to the embodiments shown, but is to be accordedthe widest scope consistent with the principles and features disclosedherein.

In addition, while a particular feature of the invention may have beendisclosed with respect to only one of several embodiments, such featuremay be combined with one or more other features of the other embodimentsas may be desired. It is therefore, contemplated that the claims willcover any such modifications or embodiments that fall within the truescope of the invention.

The various diagrams may depict an example architectural or otherconfiguration for the invention, which is done to aid in understandingthe features and functionality that can be included in the invention.The invention is not restricted to the illustrated example architecturesor configurations, but the desired features can be implemented using avariety of alternative architectures and configurations. Indeed, it willbe apparent to one of skill in the art how alternative functional,logical or physical partitioning and configurations can be implementedto implement the desired features of the invention. In addition, amultitude of different constituent module names other than thosedepicted herein can be applied to the various partitions. Additionally,with regard to flow diagrams, operational descriptions and methodclaims, the order in which the steps are presented herein shall notmandate that various embodiments be implemented to perform the recitedfunctionality in the same order unless the context dictates otherwise.

Terms and phrases used in this document, and variations thereof, unlessotherwise expressly stated, should be construed as open ended as opposedto limiting. As examples of the foregoing: the term “including” shouldbe read as meaning “including, without limitation” or the like; the term“example” is used to provide exemplary instances of the item indiscussion, not an exhaustive or limiting list thereof; the terms “a” or“an” should be read as meaning “at least one”, “one or more” or thelike; and adjectives such as “conventional”, “traditional”, “normal”,“standard”, “known” and terms of similar meaning should not be construedas limiting the item described to a given time period or to an itemavailable as of a given time, but instead should be read to encompassconventional, traditional, normal, or standard technologies that may beavailable or known now or at any time in the future. Likewise, wherethis document refers to technologies that would be apparent or known toone of ordinary skill in the art, such technologies encompass thoseapparent or known to the skilled artisan now or at any time in thefuture.

A group of items linked with the conjunction “and” should not be read asrequiring that each and every one of those items be present in thegrouping, but rather should be read as “and/or” unless expressly statedotherwise. Similarly, a group of items linked with the conjunction “or”should not be read as requiring mutual exclusivity among that group, butrather should also be read as “and/or” unless expressly statedotherwise. Furthermore, although items, elements or components of theinvention may be described or claimed in the singular, the plural iscontemplated to be within the scope thereof unless limitation to thesingular is explicitly stated.

The presence of broadening words and phrases such as “one or more”, “atleast”, “but not limited to” or other like phrases in some instancesshall not be read to mean that the narrower case is intended or requiredin instances where such broadening phrases may be absent. The use of theterm “module” does not imply that the components or functionalitydescribed or claimed as part of the module are all configured in acommon package. Indeed, any or all of the various components of amodule, whether control logic or other components, can be combined in asingle package or separately maintained and can further be distributedacross multiple locations.

Unless stated otherwise, terms such as “first” and “second” are used toarbitrarily distinguish between the elements such terms describe. Thus,these terms are not necessarily intended to indicate temporal or otherprioritization of such elements.

Additionally, the various embodiments set forth herein are described interms of exemplary block diagrams, flow charts and other illustrations.As will become apparent to one of ordinary skill in the art afterreading this document, the illustrated embodiments and their variousalternatives can be implemented without confinement to the illustratedexamples. For example, block diagrams and their accompanying descriptionshould not be construed as mandating a particular architecture orconfiguration.

All publications and patents mentioned in the above specification areherein incorporated by reference. Various modifications and variationsof the described method and system of the invention will be apparent tothose skilled in the art without departing from the scope and spirit ofthe invention. Although the invention has been described in connectionwith specific preferred embodiments, it should be understood that theinvention as claimed should not be unduly limited to such specificembodiments. Indeed, various modifications of the described modes forcarrying out the invention which are obvious to those skilled in thefield or any related fields are intended to be within the scope of thefollowing claims.

One skilled in the art will recognize that different embodiments may beformed in a similar manner having different characteristics dependingupon need, performance, or some other criteria. It will thus beappreciated by those skilled in the art that changes could be made tothe embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that theinvention disclosed herein is not limited to the particular embodimentsdisclosed, but it is intended to cover modifications within the spiritand scope of the present invention as defined by the appended claims.

Although this invention has been described in conjunction with specificembodiments thereof, many alternatives, modifications and variationswill be apparent to those skilled in the art. Accordingly, theembodiments of the invention as set forth herein are intended to beillustrative, not limiting. Various changes may be made withoutdeparting from the true spirit and full scope of the invention as setforth herein.

Although the invention has been described in conjunction with specificpreferred and other embodiments, it is evident that many substitutions,alternatives and variations will be apparent to those skilled in the artin light of the foregoing description. Accordingly, the invention isintended to embrace all of the alternatives and variations that fallwithin the spirit and scope of the appended claims. For example, itshould be understood that, in accordance with the various alternativeembodiments described herein, various systems, and uses and methodsbased on such systems, may be obtained. The various refinements andalternative and additional features also described may be combined toprovide additional advantageous combinations and the like in accordancewith the present invention. Also as will be understood by those skilledin the art based on the foregoing description, various aspects of thepreferred embodiments may be used in various subcombinations to achieveat least certain of the benefits and attributes described herein, andsuch subcombinations also are within the scope of the present invention.All such refinements, enhancements and further uses of the presentinvention are within the scope of the present invention.

What is claimed is:
 1. A fluid sample testing apparatus comprising: ahousing with a test chamber and a first fluid collector tube of a firstdiameter and a second fluid collector tube of a second diameter, whereinthe test chamber is in fluid communication with the first fluidcollector tube; a sample holding container in fluid communication withthe second fluid collector tube; and first and second fluid collectors,wherein the first fluid collector is adapted for insertion into thefirst fluid collector tube and upon insertion into the first fluidcollector tube pressure is generated to release fluid from the firstfluid collector into the test chamber via an opening between the testchamber and the first fluid collector tube, wherein air passes outsideof the apparatus from the test chamber via an opening from the testchamber into the first fluid collector tube, and wherein the secondfluid collector is adapted for insertion into the second fluid collectortube concurrently with insertion of the first fluid collector into thefirst fluid collector tube and upon insertion into the second fluidcollector tube pressure is generated to release fluid from the secondfluid collector into the sample holding container, wherein air passesoutside of the apparatus from the second fluid collector tube.
 2. Theapparatus of claim 1, wherein the first fluid collector has an uppersealing portion such that upon substantially complete insertion into thefirst fluid collector tube the upper sealing portion seals the openingbetween the test chamber and the first fluid collector swab tube.
 3. Theapparatus of claim 1, wherein the second fluid collector tube has ashoulder portion in proximity to the sample holding container of adiameter smaller than the second diameter, wherein the second fluidcollector has a lower sealing portion such that upon substantiallycomplete insertion into the second fluid collector tube the lowersealing portion seals the sample holding container from an upper portionof the second fluid collector tube.
 4. The apparatus of claim 1, whereinthe first and second fluid collectors comprise individual single swabscoupled together with a locked cap.
 5. The apparatus of claim 1, whereinthe second diameter is greater than the first diameter.
 6. The apparatusof claim 1, wherein the test chamber has a top cap connected to thehousing that is sealed from outside of the apparatus.
 7. The apparatusof claim 1, further comprising a cassette for holding one or a pluralityof test strips, wherein the cassette includes one or more channels forholding the one or more test strips and includes at least a firstchannel for holding a first strip, the first channel having a pluralityof projections from each of two opposite side walls of the firstchannel, wherein the plurality of projections define a center portion inwhich the first strip is positioned, wherein the plurality ofprojections position the first strip to reduce or prevent contactbetween the first strip and the side walls of the first channel, whereinthe first channel also has a floor having a plurality of raisedportions, wherein the plurality of raised portions position the firststrip to reduce or prevent contact between the first strip and the floorof the first channel.
 8. A fluid sample testing apparatus comprising: ahousing with a test chamber and a first fluid collector tube of a firstdiameter and a second fluid collector tube of a second diameter, whereinthe test chamber is in fluid communication with the first fluidcollector tube; a sample holding container in fluid communication withthe second fluid collector tube; first and second fluid collectors,wherein the first fluid collector is adapted for insertion into thefirst fluid collector tube and upon insertion into the first fluidcollector tube pressure is generated to release fluid from the firstfluid collector into the test chamber via an opening between the testchamber and the first fluid collector tube, wherein air passes outsideof the apparatus from the test chamber via an opening from the testchamber into the first fluid collector tube, and wherein the secondfluid collector is adapted for insertion into the second fluid collectortube concurrently with insertion of the first fluid collector into thefirst fluid collector tube and upon insertion into the second fluidcollector tube pressure is generated to release fluid from the secondfluid collector into the sample holding container; a gasket positionedin the second fluid collector tube having an upper portion for engaginga wall of the second fluid collector tube and a lower portion of smallerdiameter than the upper portion for insertion into an opening of thesample holding container, wherein the gasket is positioned at an upperlocation in the second fluid collector tube upon insertion of the secondfluid collector into the second fluid collector tube, wherein the gasketis positioned at a lower location in the second fluid collector tubeafter insertion of the second fluid collector into the second fluidcollector tube and at the lower location the gasket forms a seal withthe sample holding container, wherein air passes outside of theapparatus from the second fluid collector tube before the gasket ispositioned at the lower location.
 9. The apparatus of claim 8, whereinthe first fluid collector has an upper sealing portion such that uponsubstantially complete insertion into the first fluid collector tube theupper sealing portion seals the opening between the test chamber and thefirst fluid collector swab tube.
 10. The apparatus of claim 8, whereinthe first fluid collector has a lower sealing portion adapted to form asliding seal between the lower sealing portion and a surface wall of thefirst fluid collector tube as the first fluid collector is inserted intothe first fluid collector tube.
 11. The apparatus of claim 10, whereinthe upper sealing portion is adapted to form a fixed seal for theopening between the test chamber and the first fluid collector tube andis of shape different from the lower sealing portion.
 12. The apparatusof claim 11, wherein the upper sealing portion forms a stopper seal forthe opening between the test chamber and the first fluid collector tube,and the lower sealing portion forms a syringe plunger seal between thelower sealing portion and a surface wall of the first fluid collectortube.
 13. The apparatus of claim 12, wherein the lower sealing portionis formed to have a plurality of spaced apart o-ring portions to formthe syringe plunger seal.
 14. The apparatus of claim 12, wherein thelower sealing portion is formed to have a textured surface to form thesyringe plunger seal.
 15. The apparatus of claim 8, further comprising acassette for holding one or a plurality of test strips, wherein thecassette includes one or more channels for holding the one or more teststrips and includes at least a first channel for holding a first strip,the first channel having a plurality of projections from each of twoopposite side walls of the first channel, wherein the plurality ofprojections define a center portion in which the first strip ispositioned, wherein the plurality of projections position the firststrip to reduce or prevent contact between the first strip and the sidewalls of the first channel, wherein the first channel also has a floorhaving a plurality of raised portions, wherein the plurality of raisedportions position the first strip to reduce or prevent contact betweenthe first strip and the floor of the first channel.
 16. A ventedfluid-based testing device comprising: a housing with cylindricalinterior surface defining an elongate chamber, the housing having anupper opening for receiving a sampling assembly, a sample vial receivingstructure at a lower end of the housing with a saliva sample outlet; asample vial attachable to the sample receiving structure; the samplingassembly comprising a first end with a handle, a second opposite endwith a compressible sample collecting sponge, a shaft portion extendingbetween the handle and the collecting sponge, and a seal positioned onthe shaft portion intermediate the sample connecting sponge and thehandle, wherein when the sampling assembly is received by the housingwith the second end in first, the sampling assembly has a first positionwhere the compressible sample collecting sponge is not compressed, asecond position where the sponge is partially compressed, and a thirdfull insertion position where the sponge is further compressed, whereinwhen a sample vial is attached to the sample vial receiving structure,the housing at least partially defines a vent pathway from an interiorof the sample vial to exterior the housing; the device furthercomprising a valve member engaged with the housing and having a ventpath non-obstructing position and a second vent path obstructingposition, the valve member movable from the non-obstructing position tothe obstructing position by the sampling assembly when the samplingassembly is moved from the second position to the third full insertionposition.
 17. The device of claim 16, wherein the sample vial receivingstructure is configured as threads, and wherein the vial has cooperatingthreads.
 18. The device of claim 17, wherein the vent path is defined bythe interface of the vial receiving structure and the cooperatingthreads of the vial.
 19. The device of any of claims 20-22, wherein thevalve member is formed of an elastomeric material has an annular portionthat is sized for and engages the cylindrical interior surface of thehousing, the valve member.
 20. The device of claim 19, wherein when thesampling assembly moves from the second position to the third fullinsertion position, the valve member slidingly moves in the elongatechamber to seat on an upper lip of the sample receiving vial at theinterface when the sampling assembly in in the third full insertionposition thereby obstructing the vent path.